Status:
COMPLETED
Prospective Analysis of Hypersensitivity Reactions to Oxaliplatin
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Sanofi
Conditions:
Colorectal Cancer
Esophageal Cancer
Eligibility:
All Genders
18+ years
Brief Summary
This research study will examine how often hypersensitivity, or allergic reactions, occur in patients receiving the chemotherapy medication oxaliplatin. Hypersensitivity reactions can vary from a tran...
Detailed Description
* Participants will come in for chemotherapy treatment as scheduled by their oncologist. The frequency of the visits will depend upon the chemotherapy regimen the participant is receiving. * With each...
Eligibility Criteria
Inclusion
- 18 years of age or older
- Histologically or cytologically confirmed colorectal cancer, esophageal cancer, gastric cancer, small bowel cancer, hepatobiliary cancer and pancreatic cancer
- Patients must be eligible for treatment with oxaliplatin
- ECOG Performance Status of 2 or less
- Adequate bone marrow, renal and hepatic function as outlined in the protocol
- Patients must have recovered from both the acute and late effects of any prior surgery, radiotherapy or other antineoplastic therapy
- Patients may participate in monitoring for hypersensitivity and skin testing if they are receiving oxaliplatin as part of another clinical trial and allowed by that trial. Patients cannot receive oxaliplatin through the desensitization protocol if they are part of another clinical trial.
Exclusion
- Prior treatment with oxaliplatin
- Active infection or with a fever of 101.3 or higher within 3 days of the first scheduled days of protocol treatment
- Patients with active CNS metastases. Patients with stable CNS disease, who have undergone radiotherapy at least 4 weeks prior to the planned first protocol treatment and who have been on a stable dose of corticosteroids for greater than 3 weeks are eligible.
- Patients with known hypersensitivity to any of the components of oxaliplatin or chemotherapeutic agent used in combination with oxaliplatin
- Patients who have received radiotherapy to more than 25% of their bone marrow; or patients who received any radiotherapy within 4 weeks of study entry
- Peripheral neuropathy of grade 2 or higher
- Patients who are pregnant or lactating
- Any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with the patient's ability to sign informed consent, cooperate and participate in teh study, or interfere with the interpretation of the results.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2022
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT00831571
Start Date
February 1 2009
End Date
April 1 2022
Last Update
April 18 2022
Active Locations (1)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115